BioAssist, Inc.


Preclinical Testing Services

Principals

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Dr. Karen J. Whitehair

Veterinary Specialty Certifications
Other Certifications
Education
Corporate Experience
Academic Experience
Contract Research Experience
Relevant Continuing Education

Dr. Jon G. Whitehair

Veterinary Specialty Certifications
Other Certifications
Education
Corporate Experience
Academic Experience
Private Practice
Contract Research Experience
Relevant Continuing Education

Dr. Karen J. Whitehair

Veterinary Specialty Certifications

  • Diplomate, American College of Veterinary Surgeons, 1993

  • Diplomate, American College of Veterinary Anesthesiologists, 1994

Other Certifications

  • US Regulatory Affairs Certification, 2002

  • European Union (EU) Regulatory Affairs Certification, 2004
  • Registered Quality Assurance Professional-Good Laboratory Practice, 2002; Recertification October 2005, October 2008, October 2011
  • Regulatory Affairs Recertification December 2005, December 2008, December 2011

Education

  • M.S., School of Veterinary Medicine, Purdue University, Lafayette, IN, 1988 - 1991

  • D.V.M., College of Veterinary Medicine, Colorado State University, Ft. Collins, CO, 1983 - 1987
  • B.S., Biochemistry, University of Wisconsin, Madison, 1975 - 1979

Corporate Experience

  • Principal, BioAssist, Inc., Vacaville, CA, 2002 - present

  • Senior Clinical Veterinarian (Study Director, Anesthesiologist, Surgeon, Perfusionist, Technical Staff Supervisor, IACUC Committee Member), BioSurg, Inc., Winters, CA, 2000 - 2002
  • Chief of Anesthesia and Surgery, Senior Clinical Veterinarian (Anesthesiologist, Surgeon), Covance Research Products, Berkeley, CA, 1998 - 2000
  • Chief of Anesthesia and Surgery, Senior Clinical Veterinarian (Anesthesiologist, Surgeon), Berkeley Antibody Company, Berkeley, CA, 1997 - 1998
  • Staff Anesthesiologist, Animal Medical Center, New York, NY, 1995 - 1997
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Academic Experience

  • Clinical Instructor, Anesthesiology, Veterinary Medical Teaching Hospital, University of California, Davis, CA, 1994 - 1995

  • Resident, Anesthesiology and Critical Patient Care, Veterinary Medical Teaching Hospital, University of California, Davis, CA, 1991 - 1994
  • Resident, Large Animal Surgery, Veterinary Medical Teaching Hospital, Purdue University, Lafayette, IN, 1988 - 1991
  • Intern, Equine Medicine and Surgery, College of Veterinary Medicine, Kansas State University, Manhattan, KS, 1987 - 1988

Contract Research Experience

Karen has served as study director for GLP studies testing the following devices: coronary artery restenosis prevention devices, sutureless aorto-coronary anastomosis systems, passive ventricular support devices, vascular closure systems, lung reduction devices, ventricular support devices, cerebral aneurysm treatment devices, continuous glucose monitoring devices and as study director for non-GLP studies testing the following devices: plasma extraction devices, coronary restenosis prevention devices, lung reduction devices, ventricular support devices, and others. Karen has been a study surgeon in GLP and non-GLP studies testing the following devices: off pump aorto-coronary artery grafting, left and bi-ventricular assist devices, ventricular support devices, interpositional grafts and others and study perfusionist for implantation of stentless aortic bioprostheses and mitral valve prostheses. She has developed SOPs related to use of anesthesia, cardiopulmonary bypass and autotransfusion equipment, and anesthetic management of a variety of species, cardiopulmonary bypass management, operation and maintenance of diagnostic imaging equipment, and other equipment SOPs and has provided expertise in anesthesia and critical patient care, general surgical services, and technical staff training for three contract research organizations.

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Relevant Continuing Education

  • Regulatory Affairs Professional Society, Bay Area Chapter, 2012 FDA Pacific Region Update, San Mateo, CA, July 27, 2012

  • RAPS Online Course Ethics and Ethics Simulation, October 19, 2011
  • RAPS Online Course Medical Devices: Compliance and Audits, August 13, 2011
  • RAPS Online Course Good Laboratory Practices, August 13, 2011
  • RAPS San Francisco Chapter 2010 Pacific Region Update, July 30, 2010
  • American Society of Quality-Biomedical Division and Regulatory Affairs Professional Society, San Francisco Chapter Sponsored Workshop on Documenting Key Quality and Regulatory Processes, Foster City, CA, April 30, 2010
  • Medical Devices Submission & Compliance Strategies RAPS Webcast, April 12 & 13, 2010
  • California Perfusion Society, 25th Annual Tahoe Fall Symposium, South Lake Tahoe, CA, September 12-15, 2008
  • Regulatory Affairs Professional Webcast: Risk Analysis Techniques for Medical Devices. June 18, 2008
  • Regulatory Affairs Professional Horizons Conference and Exhibition, San Francisco, CA, March 26-28, 2008
  • California Perfusion Society, 23rd Annual Tahoe Fall Symposium, South Lake Tahoe, CA, September 9-10, 2006
  • St. Jude Medical Sponsored Wetlab, Aortic and Mitral Heart Valve Placement, UCD Medical Center, May 23, 2006
  • Regulatory Affairs Professional Webcast, Pre-Market Approval (PMA): Module I, May 17, 2006
  • Clinical Device Webcast, Pre-IDE and IDE: Processes, Requirements and Achieving Success, May 9, 2006,
  • American Society of Quality-Biomedical Division and Regulatory Affairs Professional Society, San Francisco Chapter Sponsored Seminar, "Emerging Regulatory Concerns", Santa Clara, CA, April 28, 2006
  • ADInstruments, Inc., Working Heart Lab, Pacific BioLabs, Hercules, CA; April 8, 2006
  • Regulatory Affairs Professional, San Francisco Chapter, "Regulatory Challenges for RA/QA Leaders", Santa Clara, CA, February 24, 2006
  • Regulatory Affairs Professional Webcast,"Combination Products";January 11, 2006
  • Clinical Device Group, Inc., "The Successful 510(k)"; Self Study July 22-23, 2005
  • American Society of Quality-Biomedical Division and Regulatory Affairs Professional Society, San Francisco Chapter Sponsored Seminar, "Effective Implementation of ISO 13485:2003", Santa Clara, CA, April 22, 2005
  • American Association for Thoracic Surgery 85th Annual Meeting, San Francisco, CA, April 11-13, 2005
  • American Association for Thoracic Surgery, "Adult Cardiac Symposium", San Francisco, CA, April 10, 2005
  • Regulatory Affairs Professional, San Francisco Chapter, "Risk Management Program", Foster City, February 25, 2005
  • Cardiothoracic Research and Education Forum (CREF), 25th Annual San Diego Cardiothoracic Surgery Symposium/Science and Techniques of Perfusion, San Diego, CA, February 10-13, 2005
  • California Perfusion Society, 21st Annual Tahoe Fall Symposium, South Lake Tahoe, CA, September 24-26, 2004
  • Regulatory Affairs Professional, San Francisco Chapter, "EU RAC Peer Review", Santa Clara, CA, August 28, 2004
  • Regulatory Affairs Professional, San Francisco Chapter, "FDA Update", San Mateo, CA, July 23,2004
  • Regulatory Affairs Medical Device Conference and Tabletop Exhibition, Santa Clara, CA, May 24-25 2004
  • Regulatory Affairs Professional Preconference Workshop, "Overview of European Regulatory Requirements for Drugs, Biologics, and Medical Devices", Santa Clara, CA, May 23, 2004
  • Society of Quality Assurance Annual Meeting, "Reporting Audit Findings", "FDA-GLP Regulatory Update", "Medical Device Topics" Reno, NV, April 27 2004
  • Society of Quality Assurance, Preconference Training, "Good Clinical Practice Fundamentals” and "Advanced GCP - Electronic Records in Clinical Trials: Record Integrity Issues and Regulatory Expectations", Reno, NV, April 25-26, 2004
  • Regulatory Affairs Professional, San Francisco Chapter, "How to Implement and Maintain an Effective Corrective and Preventative Action (CAPA) System", San Mateo, CA, April 23, 2004
  • Regulatory Affairs Professional Education program, “Clinical Issues”, San Diego, California, April 28-29, 2003
  • Preconference Training, Society of Quality Assurance, “A Day in the Life of a GLP Auditor”, Albuquerque, New Mexico, October 15, 2002
  • Regulatory Affairs Professionals Annual Meeting, Washington, DC, October 7-9, 2002
  • Regulatory Affairs Professional Preconference Workshop, “Overview of US Regulatory Requirements for Drugs, Biologics, and Devices”, Washington, DC, October 6, 2002
  • Regulatory Affairs Medical Device Conference and Tabletop Exhibition, San Francisco, California, March 2002
  • American Society of Anesthesiologists Annual Meetings, 1996-2001
  • Computer Courses: Creating Web Pages, Advanced Web Pages, Microsoft Access, 2004, Digital Photography Output, Introduction to XP, 2003, Excel 97-Introduction, Database Management, Word 97-Introduction, Word 97-Intermediate, 2001
  • Other Courses: How to Write a Business Plan, 2004, Accounting Fundamentals, Fundamentals of Supervision and Management, Introduction to QuickBooks, Achieving Success with Difficult People, Starting a Consulting Practice, 2003
  • GLPs for Study Directors and Monitors, Reno, NV, April 18-20 2001
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Dr. Jon G. Whitehair

Veterinary Specialty Certifications

  • Diplomate, American College of Veterinary Surgeons, 1994

Other Certifications

  • Registered Quality Assurance Professional-Good Laboratory Practice, 2001; Recertification October 2004

  • US Regulatory Affairs Certification, 2001; Recertification December 2004

Education

  • Certificate in Personal Financial Planning, Kansas State University, Manhattan, KS, 2003

  • D.V.M. (Summa Cum Laude), College of Veterinary Medicine, Kansas State University, Manhattan, KS, 1984 - 1988

  • B.S. (Magna Cum Laude), College of Agriculture, Kansas State University, Manhattan, KS, 1981 - 1984
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Corporate Experience

  • Principal, BioAssist, Inc., Vacaville, CA, 2002 - present

  • Senior Research Veterinarian (Chief Operating Officer, Study Director, Surgeon, IACUC Committee Member), BioSurg, Inc., Winters, CA, 1997 - 2002
  • Staff Surgeon, Animal Medical Center, New York, NY, 1995 - 1997

Academic Experience

  • Lecturer, Small Animal Surgery, Department of Surgical and Radiological Sciences, University of California, Davis, CA, 1993 - 1995

  • Resident, Small Animal Surgery, Veterinary Medical Teaching Hospital, University of California, Davis, CA, 1990 - 1993

Private Practice

  • Small Animal Private Practice, Indianapolis, IN, 1988 - 1990

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Contract Research Experience

Jon has served as study director for GLP studies testing the following devices: robotic surgery system, vein arterialization system, radiofrequency tissue ablation device, mitral and aortic valve bioprostheses, implantable pacemakers and defibrillators, coronary artery stent system (combination product), stentless aortic valve bioprostheses coronary artery bypass graft and urinary incontinence devices. Jon has served as study director for non-GLP studies testing the following devices: transmyocardial revascularization, venous valve bioprostheses, coronary artery stents, neurovascular devices, defibrillators, sutureless aorto-coronary anastomosis systems, and bariatric surgery devices. Jon has served as study surgeon in GLP and non-GLP studies testing the following devices: minimally invasive cardiac surgery platforms and instrumentation, ultra-profound hypothermia solutions, on-pump aorto-coronary artery grafting, off pump aorto-coronary artery grafting, stentless pulmonary valve, stentless aortic valve, aortic root replacement, venous valve bioprostheses, left and bi-ventricular assist devices and skin expanders.

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Relevant Continuing Education

  • Regulatory Affairs Professional Society, Bay Area Chapter, 2012 FDA Pacific Region Update, San Mateo, CA, July 27, 2012

  • American Society of Quality-Biomedical Division and Regulatory Affairs Professional Society, San Francisco Chapter Sponsored Workshop on Documenting Key Quality and Regulatory Processes, Foster City, CA, April 30, 2010
  • California Perfusion Society, 25th Annual Tahoe Fall Symposium, South Lake Tahoe, CA, September 12-15, 2008
  • California Perfusion Society, 23rd Annual Tahoe Fall Symposium, South Lake Tahoe, CA, September 9-10, 2006
  • St. Jude Medical Sponsored Wetlab, Aortic and Mitral Heart Valve Placement, UCD Medical Center, May 23, 2006
  • Regulatory Affairs Professional Webcast, Pre-Market Approval (PMA): Module I, May 17, 2006
  • Clinical Device Webcast, Pre-IDE and IDE:cProcesses, Requirements and Achieving Success, May 9, 2006
  • American Society of Quality-Biomedical Division and Regulatory Affairs Professional Society, San Francisco Chapter Sponsored Seminar, "Emerging Regulatory Concerns", Santa Clara, CA, April 28, 2006
  • Regulatory Affairs Professional, San Francisco Chapter, "Regulatory Challenges for RA/QA Leaders", Santa Clara, CA, February 24, 2006
  • Regulatory Affairs Professional Webcast,"Combination Products"; January 11, 2006
  • American Society of Quality-Biomedical Division and Regulatory Affairs Professional Society, San Francisco Chapter Sponsored Seminar, "Effective Implementation of ISO 13485:2003", Santa Clara, CA, April 22, 2005
  • American Association for Thoracic Surgery 85th Annual Meeting, San Francisco, CA, April 11-13, 2005
  • American Association for Thoracic Surgery, "Congential Heart Disease Symposium", San Francisco, CA, April 10, 2005
  • Regulatory Affairs Professional, San Francisco Chapter, "Risk Management Program", Foster City, February 25, 2005
  • Cardiothoracic Research and Education Forum (CREF), 25th Annual San Diego Cardiothoracic Surgery Symposium/Science and Techniques of Perfusion, San Diego, CA, February 10-13, 2005
  • AcuNav Inracardiac Echocardiography Peer Training, Mountain View, CA, January 29, 2005
  • California Perfusion Society, 21st Annual Tahoe Fall Symposium, South Lake Tahoe, CA, September 24-26, 2004
  • Regulatory Affairs Professional, San Francisco Chapter, "EU RAC Peer Review", Santa Clara, CA, August 28, 2004
  • Regulatory Affairs Professional, San Francisco Chapter, "FDA Update", San Mateo, CA, July 23,2004
  • Regulatory Affairs Medical Device Conference and Tabletop Exhibition, Santa Clara, CA, May 24-25 2004
  • Regulatory Affairs Professional Preconference Workshop, "Overview of European Regulatory Requirements for Drugs, Biologics, and Medical Devices", Santa Clara, CA, May 23, 2004
  • Society of Quality Assurance, Preconference Training, "Principles of Computer Validation for the QA Professional" and "Advanced Concepts in Computer Validation", Reno, NV, April 25-26, 2004
  • Society of Quality Assurance Annual Meeting, "Measuring the Performance of the Quality Assurance Unit", "FDA-GLP Regulatory Update", "Medical Device Topics" Reno, NV, April 27 2004
  • Regulatory Affairs Professional, San Francisco Chapter, "How to Implement and Maintain an Effective Corrective and Preventative Action (CAPA) System", San Mateo, CA, April 23, 2004
  • Slocum Enterprises, Inc., "Tibial Plateau Leveling Osteotomy (TPLO) Course, Eugene Oregon, October 19-20, 2003
  • Regulatory Affairs Professional Education program, “Clinical Issues”, San Diego, California, April 28-29, 2003
  • Regulatory Affairs Professional Society, "Critical Issues for Startup and Small Companies", San Francisco, CA, January 27-28, 2003
  • Regulatory Affairs Professionals Annual Meeting, Washington, DC, October 7-9, 2002
  • Regulatory Affairs Medical Device Conference and Tabletop Exhibition, San Francisco, California, March 2002
  • Regulatory Affairs Professional Society, San Francisco Chapter, Medical Device, Drug and Biologics Regulatory Review Sessions, 2001
  • American Society of Anesthesiologists Annual Meetings, 1996, 1997, 2000, 2001
  • GLPs for Study Directors and Monitors, Reno, NV, April 18-20 2001
  • Regulatory Affairs Professional Society, Principles and Practice of Regulatory Affairs, San Francisco, CA, 2000
  • Institute for International Research, Medical Device Division – How to Get to Market with Medical Devices – 510(k)s, PMAs and IDEs, San Diego, CA, 1999
  • Institute for International Research, Medical Device Division – Workshop: Handling Modifications to Approved and Investigational Medical Devices, San Diego, CA, 1999
  • Institute for International Research, Medical Device Division – Panel Discussion: Advertising and Promotion of Medical Devices, San Diego, CA, 1999
  • Seminar on In Vitro Diagnostic Directive, Medical Device Directive and 510(k) submissions, TUV Rheinland, Pleasanton, CA, 1999
  • Orthopedic Tissue Engineering, 2nd Annual NMHCC Bio/Technology Conference, Boston, MA, 1998
  • Meniscus and Articular Cartilage Repair, NMHCC Bio/Technology Post-Conference Symposium, Boston, MA, 1998
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